VISTOGARD Drug Patent Profile

✉ Email this page to a colleague

▶ Start for $1
Remove trial restrictions

When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

Try a Trial

Summary for VISTOGARD

International Patents:	175
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	385
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in VISTOGARD?	VISTOGARD excipients list
DailyMed Link:	VISTOGARD at DailyMed

Drug patent expirations by year for VISTOGARD

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VISTOGARD

Generic Entry Date for VISTOGARD^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 208159 Dosage: GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VISTOGARD

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

Anatomical Therapeutic Chemical (ATC) Classes for VISTOGARD

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VISTOGARD is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VISTOGARD

Acylated uridine and cytidine and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

FDA Regulatory Exclusivity protecting VISTOGARD

EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.
Exclusivity Expiration: ⤷ Try a Trial

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for VISTOGARD

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VISTOGARD

See the table below for patents covering VISTOGARD around the world.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Norway	317199		⤷ Try a Trial
European Patent Office	0768883		⤷ Try a Trial
Mexico	9307765	COMPOSICIONES FARMACEUTICAS A BASE DE PRECURSORES NUCLEOTIDOS DE PIRIMIDINA PARA EL TRATAMIENTO DE INFLAMACIONES SISTEMICAS Y HEPATITIS INFLAMATORIA.	⤷ Try a Trial
Russian Federation	2203669	СПОСОБЫ ЛЕЧЕНИЯ СЕПСИСА И ВОСПАЛЕНИЙ С ПОМОЩЬЮ ОКСИПУРИНОВЫХ НУКЛЕОЗИДОВ (METHOD FOR TREATING SEPSIS AND INFLAMMATIONS DUE TO OXYPURINE NUCLEOSIDES)	⤷ Try a Trial
South Africa	9506679		⤷ Try a Trial
Japan	H07228535	MEDICAL COMPONENT CONTAINING ACYL DERIVATIVE OF URIDINE OR CYTIDINE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VISTOGARD

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	1790063-0	Sweden	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470	SPC/GB17/049	United Kingdom	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
1849470	CA 2017 00036	Denmark	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470	2017/033	Ireland	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470	LUC00036	Luxembourg	⤷ Try a Trial	PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	2017C/028	Belgium	⤷ Try a Trial	PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description